FDA Inspection
CSPC Ouyi Pharmaceutical Co., Ltd.CSPC Ouyi Pharmaceutical Co., Ltd. – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns CSPC Ouyi Pharmaceutical Co., Ltd., with an inspection on May 17, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · bfea5143-8ec4-424d-841e-d69ed678b577
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091103
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.110(b)In-process conformity - examination, sample testing
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Other FDA inspections of CSPC Ouyi Pharmaceutical Co., Ltd.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | Not classified | Office of Inspections and Investigations | |
| June 15, 2018 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| October 20, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CSPC Ouyi Pharmaceutical Co., Ltd.
- FDA Inspection 1239361 - 2024-09-05
- FDA Inspection 1058543 - 2018-06-15
- FDA Inspection 1036247 - 2017-10-20
- FDA Inspection 1021148 - 2017-08-02
- FDA Inspection 945964 - 2015-09-25
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